Operational Highlights
- In
November 2023 , BioStem was awarded a Q code for VENDAJE AC® by theCenters for Medicare and Medicaid Services (CMS). The Healthcare Common Procedure Coding System (HCPCS) code will be effectiveJanuary 1st, 2024 , and will ensure broader access to the company’s Vendaje® product. - Also in November, the Company closed an oversubscribed private placement for gross proceeds of
$2 million . - In
October 2023 , BioStem announced the opening of the first site for its clinical trial, evaluating its Vendaje® tissue allograft in the treatment of diabetic foot ulcers (DFU). The Company receivedInvestigational Review Board (IRB) for the landmark study inSeptember 2023 . - In
September 2023 , the Company entered an agreement with leading US wound market solutions provider,Venture Medical, LLC ., for the nationwide release of its innovative product, AmnioWrap2™. Venture Medical will act as BioStem’s commercial partner as it works to bring its product portfolio to healthcare providers and patients around the country. - Also in September, BioStem entered a commercialization agreement with NovaBay Pharmaceuticals for its Amniotic Tissue Allograft, which is intended for use as a protective covering during the repair of ocular surfaces. NovaBay intends to commercialize the prescription-only product as Avenova Allograft to leverage its Avenova eye care brand and encourage use with other Avenova products. Medically necessary procedures with the Avenova Allograft will be reimbursed through Medicare.
- In
September 2023 , the Company was successfully listed on key government contract vehicles, on the Department of Defense’s Distribution and Pricing Agreement (DAPA), theDepartment of Veterans Affairs Federal Supply Schedule (FSS), and the Defense Logistics Agency’s ECAT system. This listing was made possible by BioStem’s Service-Disabled Veteran-Owned Small Business (SDVOSB) exclusive partner, Lovell Government Services.
Three-months Ending
- Net revenue of
$3.599 million for the quarter endedSeptember 30, 2023 , up 214%, compared to net revenue of$1.146 million for the quarter endedSeptember 30, 2022 . - Gross profit for the quarter ended
September 30, 2023 , was$3.292 million , or 91% of revenue, compared to$0.908 million or 79% of net revenue, for the quarter endedSeptember 30, 2022 , an increase of$2.384 million , or 12%. - Net income of
$0.367 million for the quarter endedSeptember 30, 2023 , compared to a net loss of($0.883) million for the quarter endedSeptember 30, 2022 , an increase of$1.250 million and 142%. - Adjusted EBITDA income of
$1.861 million , or 52% of net revenue, for the quarter endedSeptember 30, 2023 , compared to Adjusted EBITDA loss of($0.558) million , or (49%) of net revenue, for the quarter endedSeptember 30, 2022 , an increase of$2.419 million or 433%. See the reconciliation of GAAP net income (loss) to non-GAAP EBITDA and non-GAAP Adjusted EBITDA for each of the periods presented within the Non-GAAP Financial Measures section below.
Quarter and Year-to Date ending
The following table represents net revenue, gross margin, operating expenses, and other income (loss) for the three and nine months ended
Three months ended | Nine months ended | ||||||||||||||||||||||||||
2023 | 2022 | $ Change | % Change | 2023 | 2022 | $ Change | |||||||||||||||||||||
Net revenue | $ | 3,599,068 | $ | 1,145,755 | $ | 2,453,313 | 214 | % | $ | 5,243,570 | $ | 6,082,116 | $ | (838,546 | ) | ||||||||||||
Gross profit | $ | 3,291,831 | $ | 907,766 | $ | 2,384,065 | 263 | % | $ | 4,629,079 | $ | 5,325,378 | $ | (696,299 | ) | ||||||||||||
Gross profit % | 91 | % | 79 | % | 12 | % | 88 | % | 88 | % | |||||||||||||||||
Operating expenses | $ | 2,761,899 | $ | 1,682,749 | $ | 1,079,150 | 64 | % | $ | 9,581,565 | $ | 6,362,117 | $ | 3,219,448 | |||||||||||||
Other expense, net | $ | (162,613 | ) | $ | (112,812 | ) | $ | (49,801 | ) | -44 | % | $ | (788,955 | ) | $ | (2,424,330 | ) | $ | 1,635,375 |
Statement of Operations Highlights –Year to Date
Net revenue for the nine months ended
Gross profit for the nine months ended
Operating expenses for the nine months ended
Total other expense, net, for the nine months ended
Net loss for the nine months ended
Statement of Cashflows and Balance Sheet Highlights:
Cashflows (used in) operations was
Cashflows used in investing activities were
Cashflows provided by financing activities were
The Company maintained cash on hand as of
The Company continues to strengthen its balance sheet. The Company converted
Also, as disclosed in the footnotes to the financial statements, the Company completed its private placement in
CONSOLIDATED BALANCE SHEETS | ||||||||
(Unaudited) | ||||||||
2023 | 2022 | |||||||
Current Assets | ||||||||
Cash | $ | 109,864 | $ | 772,136 | ||||
Accounts receivable, net | 2,912,865 | 37,206 | ||||||
Inventory, net | 495,004 | 395,228 | ||||||
Prepaid expenses and other assets | 280,079 | 281,930 | ||||||
Total current assets | 3,797,812 | 1,486,500 | ||||||
Fixed Assets | ||||||||
Property, plant and equipment, net | 1,379,488 | 1,352,894 | ||||||
Right-of-use asset, net | 13,250 | 19,832 | ||||||
Intangible assets, net | 378,470 | 362,571 | ||||||
244,635 | 244,635 | |||||||
Total assets | 5,813,655 | 3,466,432 | ||||||
Current Liabilities | ||||||||
Accounts payable and accrued expenses | $ | 1,178,029 | $ | 570,115 | ||||
Salaries payable | 68,750 | 0.0 | ||||||
Accrued interest | 1,697,279 | 1,478,421 | ||||||
Short-term finance lease | 8,988 | 9,238 | ||||||
Notes payable-current | 3,831,095 | 3,018,679 | ||||||
Related party convertible notes payable | 300,000 | 300,000 | ||||||
Other convertible notes payable | 473,350 | 723,350 | ||||||
Other current liabilities | 349,250 | 228,303 | ||||||
Total current liabilities | 7,906,741 | 6,328,106 | ||||||
Long Term Liabilities | ||||||||
Long-term finance lease | 5,138 | 11,305 | ||||||
Related party notes payable | 0.0 | 0.0 | ||||||
Notes payable-long-term | 1,405,346 | 1,026,462 | ||||||
Other long-term liabilities | 22,275 | 50,512 | ||||||
Total long term liabilities | 1,432,759 | 1,088,279 | ||||||
Total liabilities | 9,339,500 | 7,416,385 | ||||||
Commitments and contingencies (Note 14) | 0.3 | 0.0 | ||||||
Stockholders' Deficit | ||||||||
Series A-1 convertible preferred stock, | 0.3 | 0.3 | ||||||
Series B-1 convertible preferred stock, | - | - | ||||||
Common stock, | 13,582 | 12,161 | ||||||
Additional paid-in capital | 39,386,493 | 33,095,921 | ||||||
(43,346 | ) | (43,346 | ) | |||||
Accumulated deficit | (42,882,574 | ) | (37,141,133 | ) | ||||
Noncontrolling interest | - | 126,444 | ||||||
Total stockholders' deficit | (3,525,845 | ) | (3,949,953 | ) | ||||
Total liabilities and stockholders' deficit | $ | 5,813,655 | $ | 3,466,432 |
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
(Unaudited) | ||||||||||||||||
Three-months ended, | Nine-months ended, | |||||||||||||||
Net Revenue | $ | 3,599,068 | $ | 1,145,755 | $ | 5,243,570 | $ | 6,082,116 | ||||||||
Cost of goods sold | 307,237 | 237,989 | 614,491 | 756,737 | ||||||||||||
Gross profit | 3,291,831 | 907,766 | 4,629,079 | 5,325,379 | ||||||||||||
Operating Expenses: | ||||||||||||||||
Professional fees | 192,580 | 276,815 | 642,259 | 623,844 | ||||||||||||
General and administrative expenses | 2,513,274 | 1,343,956 | 8,764,898 | 5,552,678 | ||||||||||||
Depreciation and amortization expense | 56,045 | 61,978 | 174,408 | 185,595 | ||||||||||||
Total operating expenses | 2,761,899 | 1,682,749 | 9,581,565 | 6,362,117 | ||||||||||||
Income (loss) from operations | 529,932 | (774,983 | ) | (4,952,486 | ) | (1,036,738 | ) | |||||||||
Other Income (Expense): | ||||||||||||||||
Loss on extinguishment of debt | - | - | - | (2,083,197 | ) | |||||||||||
Interest expense | (162,613 | ) | (110,569 | ) | (412,370 | ) | (358,203 | ) | ||||||||
Other income (expense), net | (489 | ) | (2,243 | ) | (376,585 | ) | 17,070 | |||||||||
Total other income (expense), net | (162,613 | ) | (112,812 | ) | (788,955 | ) | (2,424,330 | ) | ||||||||
Net income (loss) from operations before income taxes | 367,319 | (887,795 | ) | (5,741,441 | ) | (3,461,068 | ) | |||||||||
Income taxes | - | - | - | - | ||||||||||||
Net income (loss) | 367,319 | (887,795 | ) | (5,741,441 | ) | (3,461,068 | ) | |||||||||
Less: Net (loss) income attributable to noncontrolling interest | - | (90,567 | ) | - | 9,849 | |||||||||||
Net income (loss) attributable to | $ | 367,319 | $ | (797,228 | ) | $ | (5,741,441 | ) | $ | (3,470,917 | ) | |||||
Basic and diluted net income (loss) per share attributable to common stockholders of | $ | 0.03 | $ | (0.07 | ) | $ | (0.43 | ) | $ | (0.32 | ) | |||||
Basic and diluted weighted average common shares outstanding | 13,493,387 | 11,685,291 | 13,209,159 | 10,731,773 | ||||||||||||
NON-GAAP FINANCIALS MEASURES
The following is a reconciliation of GAAP net income (loss) to non-GAAP EBITDA and non-GAAP Adjusted EBITDA for each of the periods presented:
Three months ended | Nine months ended | ||||||||||||||||||||||||||||||
2023 | 2022 | $ Change | % Change | 2023 | 2022 | $ Change | % Change | ||||||||||||||||||||||||
Net income (loss) | $ | 367,319 | $ | (887,795 | ) | $ | 1,255,114 | 141 | % | $ | (5,741,441 | ) | $ | (3,486,685 | ) | $ | (2,254,756 | ) | 65 | % | |||||||||||
Interest expense | 162,613 | 110,569 | 52,044 | 47 | % | 412,370 | 358,203 | 54,167 | 15 | % | |||||||||||||||||||||
Depreciation and amortization | 56,045 | 61,978 | (5,933 | ) | -10 | % | 174,408 | 185,595 | (11,187 | ) | -6 | % | |||||||||||||||||||
EBITDA | $ | 585,977 | $ | (715,248 | ) | $ | 1,301,225 | 182 | % | $ | (5,154,663 | ) | $ | (2,942,887 | ) | $ | (2,211,776 | ) | 75 | % | |||||||||||
Share-based compensation | 1,274,739 | 157,106 | 1,117,633 | 5,080,362 | 2,555,573 | 2,524,790 | |||||||||||||||||||||||||
Loss on debt restructuring | - | - | - | - | 2,083,197 | (2,083,197 | ) | -100 | % | ||||||||||||||||||||||
Adjusted EBITDA | $ | 1,860,716 | $ | (558,142 | ) | $ | 2,418,858 | 433 | % | $ | (74,301 | ) | $ | 1,695,883 | $ | (1,770,184 | ) | -104 | % |
Conference Call Details
Date: Tuesday, November 14, 2023
Time: 10:30 am EDT
Webcast Link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=h6fk2xLz
Conference ID: 4373739
Participant Toll-Free Dial-In Number: 1 (888) 880-2204
Participant Toll Dial-In Number: 1 (646) 960-0414
In order to submit questions, participants must have Internet connectivity, as questions will only be addressed via the webcast. The conference call line will be in listen-only mode.
About
Forward-Looking Statements: Except for statements of historical fact, this release also contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified using words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements with respect to the operations of the Company, strategies, prospects and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: (1) the impact of any changes to the reimbursement levels for the Company’s products; (2) the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company’s products to become obsolete and if the Company does not enhance its product offerings through its research and development efforts, it may be unable to effectively compete; (4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; (5) the Company’s ability to raise funds to expand its business; (6) the Company has incurred significant losses since inception and may incur losses in the future; (7) changes in applicable laws or regulations; (8) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (9) the Company’s ability to maintain production of its products in sufficient quantities to meet demand; and (10) the COVID-19 pandemic and its impact, if any, on the Company’s fiscal condition and results of operations; You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.
Phone: 954-380-8342
Website: http://www.biostemtechnologies.com
Email: info@biostemtech.com
Twitter: @BSEM_Tech
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